(21 days)
Not Found
No
The summary describes a physical surgical suture with barbs and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is indicated for soft tissue approximation, which is a therapeutic intervention.
No
The device is described as a "TranQuill barbed device" indicated for "soft tissue approximation where use of an absorbable suture is appropriate". Its function is to approximate tissue, not to diagnose a condition.
No
The device description clearly states it is a physical, sterile, synthetic absorbable device (suture) made of polydioxanone with barbs. It is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "soft tissue approximation where use of an absorbable suture is appropriate." This describes a surgical procedure performed on the body, not a test performed on a sample taken from the body.
- Device Description: The device is a "sterile, synthetic absorbable device" designed with barbs for tissue approximation. This is a physical implant/tool used in surgery.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information about a patient's condition
- Using reagents or assays
The device is clearly a surgical suture, which is a medical device used for physical repair of tissue, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The TranQuill barbed device comprised of polydioxanone, is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
Product codes
NEW
Device Description
The TranQuill barbed device is a sterile, synthetic absorbable device that is intended for use in the approximation of soft tissue. It is comprised of polyester [poly (p-dioxanone)], dyed with D&C Violet No. 2. The device is designed with small bi-directional barbs along the long axis of the suture monofilament. It is available in diameter Size 0 through 2-0 in various lengths affixed to various needle types.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical laboratory performance testing was conducted to confirm that the TranQuill barbed device comprised of polydioxanone, conforms to the USP monograph for absorbable sutures for tensile strength (as applicable) and in vitro barb holding strength. This testing was performed in accordance with FDA's Class II Special Controls Guidance Document: Surgical Sutures, Issued June 3, 2003. Additional performance testing was conducted in order to demonstrate substantial equivalence to the predicate device including in vitro post-hydrolysis tensile testing. The results of this testing demonstrates that the TranQuill barbed device comprised of polydioxanone, is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4840 Absorbable polydioxanone surgical suture.
(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
0
510(k) Summary
| Date Prepared: | November 27, 2013 |
|---|---|
| Company: | Surgical Specialties Corporation |
| 100 Dennis Dr. | |
| Reading, PA 19606 | |
| Contact: | Kirsten Stowell |
| Regulatory Affairs Manager | |
| Phone: 610-404-3367 | |
| Fax: 610-404-3924 | |
| Email: kstowell@angio.com |
NOV 29 2013
| Device trade name: | TranQuill barbed device, comprised of Polydioxanone |
|---|---|
| Device Common Name: | Polydioxanone Absorbable Surgical Suture |
| Device classification: | Absorbable polydioxanone surgical suture |
| Product code, NEW | |
| 21 CFR 878.4840 | |
| Class II | |
| Legally marketed device to which the device is substantially equivalent: | K051609: |
| K080680 | |
| K080985 | |
| Quill Synthetic Absorbable Barbed Suture | |
| Quill TM Self-Retaining System (SRS) comprised of PDO | |
| Quill TM Self-Retaining System (SRS) comprised of PDO | |
| Description of the device: | The TranQuill barbed device is a sterile, synthetic absorbable device that is intended for use in the approximation of soft tissue. It is comprised of polyester [poly (p-dioxanone)], dyed with D&C Violet No. 2. The device is designed with small bi-directional barbs along the long axis of the suture monofilament. It is available in diameter Size 0 through 2-0 in various lengths affixed to various needle types. |
| Indications for Use: | The TranQuill barbed device comprised of dyed PDO is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate. |
.
.
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K133420 Page 2/2
Substantial The TranQuill barbed device comprised of polydioxanone has the Equivalence: same design and materials as the QuillTM Synthetic Absorbable Barbed Suture predicate device, including the same intended use and technological characteristics as the predicate device. The only difference between the proposed and predicate device is the decrease in spacing between barbs. Performance tests: Non-clinical laboratory performance testing was conducted to confirm that the TranQuill barbed device comprised of polydioxanone, conforms to the USP monograph for absorbable sutures for tensile strength (as applicable) and in vitro barb holding strength. This testing was performed in accordance with FDA's Class II Special Controls Guidance Document: Surgical Sutures, Issued June 3, 2003. Additional performance testing was conducted in order to demonstrate substantial equivalence to the predicate device including in vitro post-hydrolysis tensile testing. The results of this testing demonstrates that the TranQuill barbed
device comprised of polydioxanone, is substantially equivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three curved lines forming its body and wings. The bird is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Surgical Specialties Corporation Ms. Kirsten Stowell Regulatory Affairs Manager 100 Dennis Drive Reading, Pennsylvania 19606
January 23, 2014
Re: K133420
Trade/Device Name: TranQuill Barbed Device Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture Regulatory Class: Class II Product Code: NEW Dated: November 6, 2013 Received: November 8, 2013
Dear Ms. Stowell:
This letter corrects our substantially equivalent letter of November 29, 2013.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
3
Page 2 - Ms. Kirsten Stowell
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 ), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director For Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K133420
Device Name
TranQuill Barbed Device, comprised of Polydioxanone
Indications for Use (Describe)
The TranQuill barbed device comprised of polydioxanone, is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
[ ] Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)